What side effects are associated with this type of intervention?

Common treatments for obesity include GLP-1 receptor agonists like Semaglutide and other pharmacological agents. Semaglutide is known to cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, particularly during the initial phase of treatment. Other potential side effects include pancreatitis and, in rare cases, thyroid tumors. Bimagrumab, an activin type II receptor blocker, is less commonly used, and its side effect profile is still being studied, but it may include muscle-related issues given its mechanism of action. Overall, while these treatments can be effective for weight loss, they must be used under medical supervision to manage and mitigate potential adverse effects.

What prior FDA approvals exist?

Semaglutide, a GLP-1 receptor agonist, has been approved by the FDA for the treatment of obesity. It works by mimicking the hormone GLP-1, which helps regulate appetite and food intake. Liraglutide, another GLP-1 receptor agonist, has also been approved for weight management in individuals with obesity. These drugs have shown efficacy in promoting weight loss and improving glycemic control. Bimagrumab, an activin type II receptor blocker, is currently being studied for its potential in treating obesity, although it has not yet received FDA approval for this indication.

What other types of research exist?

Promising novel alternatives for obesity treatment in 2024 include Tirzepatide, a dual GIP and GLP-1 receptor agonist, and Setmelanotide, a melanocortin 4 receptor (MC4R) agonist. Tirzepatide has shown significant weight loss in clinical trials, while Setmelanotide is targeted for patients with specific genetic obesity disorders and has demonstrated efficacy in reducing body weight.

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Monoclonal Antibodies

Bimagrumab + Semaglutide for Obesity

Phase 2

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline 48 weeks

Summary

This trial is testing whether bimagrumab alone or with semaglutide can help overweight or obese men and women keep or increase their muscle mass while losing weight. Bimagrumab helps build or maintain muscle, and semaglutide helps reduce appetite and promote weight loss. Bimagrumab is a new agent with a unique way of working.

Who is the study for?

Adults aged 18-80 who are overweight or obese (BMI ≥ 30, or BMI ≥ 27 with related health issues like high blood pressure) can join. They must have tried to lose weight before without success and be willing to follow the study's diet and activity plans. Women able to have children need two negative pregnancy tests and must use an IUD plus a barrier method for contraception.

What is being tested?

The trial is testing Bimagrumab alone or combined with Semaglutide against a placebo in men and women who are overweight or obese. It aims to find out how effective these treatments are at helping participants lose weight, as well as their safety profiles.

What are the potential side effects?

Possible side effects of Bimagrumab may include muscle pain, nausea, diarrhea, and potential allergic reactions. Semaglutide could cause digestive problems like stomach pain, constipation, vomiting, gallbladder issues, low blood sugar levels in people with type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in body weight at 48 weeks

Secondary study objectives

Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)

Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey

Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)

+15 more

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Placebo + semaglutide 2.4 mgExperimental Treatment2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Group II: Placebo + semaglutide 1.0 mgExperimental Treatment2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group III: Bimagrumab 30 mg/kg + semaglutide 2.4 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg per the dose escalation schedule.

Group IV: Bimagrumab 30 mg/kg + semaglutide 1.0 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 30 mg/kg at baseline, and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group V: Bimagrumab 30 mg/kg + no semaglutideExperimental Treatment1 Intervention

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64.

Group VI: Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutideExperimental Treatment1 Intervention

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Group VII: Bimagrumab 10 mg/kg + semaglutide 2.4 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Group VIII: Bimagrumab 10 mg/kg + semaglutide 1.0 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group IX: Placebo to bimagrumab 30 mg/kg + no semaglutidePlacebo Group2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bimagrumab

2015

Completed Phase 3

~220

Semaglutide

2021

Completed Phase 4

~5160

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bimagrumab, an Activin Type II Receptor Blocker, promotes muscle growth and reduces fat mass by inhibiting pathways that cause muscle wasting and fat accumulation. Semaglutide, a GLP-1 Receptor Agonist, enhances insulin secretion, suppresses appetite, and slows gastric emptying, leading to reduced food intake and weight loss. These mechanisms are important for obesity patients as they offer a comprehensive approach to managing weight and reducing obesity-related health risks.